Evaluation of Daily Disposable Toric Soft Lenses Manufactured With an Alternative Hydration Process
- Conditions
- Astigmatism
- Registration Number
- NCT06967129
- Lead Sponsor
- Johnson & Johnson Vision Care, Inc.
- Brief Summary
This is a prospective, multi-site, dispensing, randomized, controlled, double-masked, bilateral wear, 2x2 crossover study to evaluate the safety and effectiveness of the test lens.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 282
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Lens Rotational Stability with Blinks At baseline per wear period Rotational stability will be assessed for each eye at least 15 minutes after lens insertion. Lens rotational stability with blinks will be defined as a binary endpoint, the percentage of eyes that achieve rotational stability with blinks ≤ 5°.
Distance (4m) Monocular High Luminance High Contrast (HLHC) logMAR Visual Acuity (VA) At each 1-week follow-up per wear period VA will be assessed monocularly under HLHC conditions at a test distance of 4 meters using ETDRS Charts.
Toric Lens Orientation At baseline per wear period Toric lens orientation (scribe mark position relative to 6 o'clock) will be assessed for each eye at 15 minutes after lens insertion. Toric lens orientation will be used to define a binary endpoint, i.e. the percentage of eyes that achieve absolute toric lens rotation ≤ 10°.
Percentage of eyes with Grade 3 or higher SLFs relating to the test lens Up to 3-week follow-up SLFs (Grade 3 or higher) related to study lens wear for the test lens will be assessed for each eye at all study visits (scheduled and unscheduled). SLFs will be evaluated and graded using the FDA Grading scale from 0 to 4, where Grade 0 represents the absence of findings and 1 to 4 representing successively worse findings. The percentage of eyes with Grade 3 or higher SLF will be analyzed and will include corneal infiltrates.
Percentage of eyes with acceptable lens fitting while wearing the test lens Up to 3-week follow-up Acceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each subject eye and used to define a binary endpoint, i.e. the percentage of eyes that achieve acceptable lens fit while wearing the test lens.
Lens fit will be deemed unacceptable if any one of the following criteria are met:
* limbal exposure at primary gaze or with extreme eye movement.
* edge lift.
* excessive movement on blink in primary gaze.
* insufficient movement in all three of the following conditions: primary gaze, up gaze, and push up test.
- Secondary Outcome Measures
Name Time Method Subjective Overall Comfort At each 1-week follow-up per wear period Subjective overall Comfort scores will be assessed using the CLUE questionnaire. CLUE™ is a validated, patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, for wearers between 18 to 65 years of age. CLUE™ scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Subjective Overall Quality of Vision At each 1-week follow-up per wear period Subjective Overall Quality of Vision scores will be assessed using the CLUE questionnaire. CLUE™ is a validated, patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, for wearers between 18 to 65 years of age. CLUE™ scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Subjective Overall Handling At each 1-week follow-up per wear period Subjective Overall Handling scores will be assessed using the CLUE questionnaire. CLUE™ is a validated, patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, for wearers between 18 to 65 years of age. CLUE™ scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Trial Locations
- Locations (20)
James R. Dugue, Optometrist
🇺🇸Mission Viejo, California, United States
Scripps Poway Eyecare & Optometry
🇺🇸San Diego, California, United States
Stam & Associates Eye Care
🇺🇸Jacksonville, Florida, United States
Omega Vision Center
🇺🇸Longwood, Florida, United States
Maitland Vision Centers - North Orlando Ave
🇺🇸Maitland, Florida, United States
Mid-State Eye
🇺🇸Clinton, Illinois, United States
Franklin Park Eye Center, P.C.
🇺🇸Franklin Park, Illinois, United States
Kannarr Eye Care - 101 North Broadway
🇺🇸Pittsburg, Kansas, United States
Complete Eye Care of Medina
🇺🇸Medina, Minnesota, United States
Advanced Eyecare - Raytown, MO
🇺🇸Raytown, Missouri, United States
The Koetting Associates
🇺🇸Saint Louis, Missouri, United States
ABQ Eye Care
🇺🇸Albuquerque, New Mexico, United States
Spectrum Eye Care
🇺🇸Jamestown, New York, United States
Sacco Eye Group
🇺🇸Vestal, New York, United States
ProCare Vision Centers
🇺🇸Granville, Ohio, United States
Professional Vision Care Inc. - Westerville
🇺🇸Westerville, Ohio, United States
Optometry Group, PLLC
🇺🇸Memphis, Tennessee, United States
Total Eye Care
🇺🇸Memphis, Tennessee, United States
Tyler Eye Associates
🇺🇸Tyler, Texas, United States
Clarke EyeCare Center
🇺🇸Wichita Falls, Texas, United States